FDA Inspection
Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc.Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc. – FDA Inspection, Oct 30, 2024
Record Details
This FDA Inspection record concerns Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc., with an inspection on October 30, 2024, issued by the Los Angeles District Office, covering human drugs.
- Inspection Date
- October 30, 2024
- Product Type
- Human Drugs
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ID · c62f11af-e228-48e4-b898-f4ae90d2c8dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1250753
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2023 | Not classified | Los Angeles District Office | |
| August 23, 2019 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| February 16, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 12, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| April 1, 2014 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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